Primary Biliary Cholangitis Trial, Not Yet Recruiting (NCT07556913)

Primary Biliary Cholangitis Trial, Not Yet Recruiting NCT07556913 Sponsor: Ipsen Condition: Primary Biliary Cholangitis

Printed from Voxsanity (voxsanity.com.au) — NCT07556913 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Primary Biliary Cholangitis

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You took at least one dose of a medication called elafibranor either within three weeks before becoming pregnant or at any point during your pregnancy.
You previously took part in this program during an earlier pregnancy and took elafibranor around the time of or during that new pregnancy — you may be able to enroll again.
You are able and willing to give your informed consent to participate (or a formal consent waiver has been approved for your situation).

Who may not be able to join:

You may not be able to join if there are concerns about your ability to fully understand and agree to the study requirements, or to reliably participate in the study (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 29 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Ipsen Medical Director, Ipsen

Phone: See e-mail

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07556913

Sponsor: Ipsen

Phase: Not Applicable

Status: Not Yet Recruiting

Condition: Primary Biliary Cholangitis

Trial contact: See e-mail

More information: https://clinicaltrials.gov/study/NCT07556913

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You took at least one dose of a medication called elafibranor either within three weeks before becoming pregnant or at any point during your pregnancy.
You previously took part in this program during an earlier pregnancy and took elafibranor around the time of or during that new pregnancy — you may be able to enroll again.
You are able and willing to give your informed consent to participate (or a formal consent waiver has been approved for your situation).

Who may not be able to join:

You may not be able to join if there are concerns about your ability to fully understand and agree to the study requirements, or to reliably participate in the study (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 29 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Not Yet Recruiting

Phase

Not Applicable

Sponsor

Ipsen

Registry

ClinicalTrials.gov

Start date

15 August 2026

Est. completion

31 January 2039

Primary endpoints

Prevalence of congenital malformations at birth

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov